美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA218490"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
66215-814-10 66215-814 HUMAN PRESCRIPTION DRUG OPSYNVI macitentan and tadalafil TABLET, FILM COATED ORAL 20240322 N/A NDA NDA218490 Actelion Pharmaceuticals US, Inc. MACITENTAN; TADALAFIL 10 mg/1; 40 mg/1 1 BLISTER PACK in 1 CARTON (66215-814-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (66215-814-01)
66215-814-30 66215-814 HUMAN PRESCRIPTION DRUG OPSYNVI macitentan and tadalafil TABLET, FILM COATED ORAL 20240322 N/A NDA NDA218490 Actelion Pharmaceuticals US, Inc. MACITENTAN; TADALAFIL 10 mg/1; 40 mg/1 1 BOTTLE in 1 CARTON (66215-814-30) / 30 TABLET, FILM COATED in 1 BOTTLE
66215-812-30 66215-812 HUMAN PRESCRIPTION DRUG OPSYNVI macitentan and tadalafil TABLET, FILM COATED ORAL 20240322 N/A NDA NDA218490 Actelion Pharmaceuticals US, Inc. MACITENTAN; TADALAFIL 10 mg/1; 20 mg/1 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE
66215-812-08 66215-812 HUMAN PRESCRIPTION DRUG OPSYNVI macitentan and tadalafil TABLET, FILM COATED ORAL 20240322 N/A NDA NDA218490 Actelion Pharmaceuticals US, Inc. MACITENTAN; TADALAFIL 10 mg/1; 20 mg/1 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)
66215-812-07 66215-812 HUMAN PRESCRIPTION DRUG OPSYNVI macitentan and tadalafil TABLET, FILM COATED ORAL 20240322 N/A NDA NDA218490 Actelion Pharmaceuticals US, Inc. MACITENTAN; TADALAFIL 10 mg/1; 20 mg/1 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE
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